Cleared Traditional

K150833 - iHealth Align Gluco-Monitoring System

K150833 is the FDA 510(k) clearance for iHealth Align Gluco-Monitoring System by Andon Health Co, Ltd.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K150833 · Andon Health Co, Ltd. · Chemistry device
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Dec 2015
Decision
249d
Days
Class 2
Risk

K150833 is an FDA 510(k) clearance for the iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monit.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 4, 2015 after a review of 249 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K150833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2015
Decision Date December 04, 2015
Days to Decision 249 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 88d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 181
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K150833.
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